Originally Published MDDI January 2003

NEWSTRENDS

Gregg Nighswonger

The 2003 agenda of the Medical Device Manufacturers Association (MDMA) will build off of the group's accomplishments of 2002, says Mark B. Leahey, MDMA's new Executive Director. Leahey's appointment was announced on December 13. Prior to that time, Leahey was the association's Director of Federal Affairs.

"The board has stated that, in the coming year, the issue of group purchasing organizations (GPOs) still remains a top priority for the association," Leahey recently told MD&DI. The group has seen some movement among the leading GPOs, "but clearly not enough to effect change and to address the anticompetitive nature of the practices," said Leahey. "We're looking to lower healthcare costs for the system. You only need to look at the paper to see that costs are spiraling out of control." He added, "Some issues will fall by the wayside, but this is not one of them. There's strong bipartisan support up on the hill, and we look forward to continuing to work on the GPO issues as a top priority."

Regarding the Medical Device User Fee & Modernization Act (MDUFMA) of 2002, Leahey said, "We have always philosophically opposed the notion of a user fee." He adds, "We think that government regulation should be funded by the government. We obviously understood that there was a groundswell here and that the economic conditions in the country warranted discussing user fees as a last resort." Noting that MDUFMA had "quite a few holes," he said, "as we move forward in 2003, the implementation of MDUFMA will be critical to make sure that manufacturers, especially small manufacturers, are protected so that overly burdensome regulations or unintended consequences of the legislation don't happen as FDA moves forward with implementation."

Leahey also believes that congressional appropriations will be critical in 2003. "In the original [MDUFMA] legislation, manufacturers agreed to pay FDA user fees for a five-year period," he said. "If the congressional appropriations weren't there, then FDA wouldn't have to meet any performance goals. We came to the table and said this makes no sense. We wanted it similar to the Prescription Drug User Fee Act, where in the pharma world the language states that if congressional appropriations aren't there, then FDA doesn't have to meet their performance goals, but industry doesn't have to pay a user fee."

He believes device makers will face a number of other issues in the coming year. "Medicare is obviously going to be a big issue," said Leahey. "We need to make sure that new medical technologies are reimbursed at adequate levels in order to foster continued innovation and pay for the research and development." He added, "The rising cost of healthcare will be important. The pharma folks have dealt with this quite a bit, and I'm sure that the device folks are seeing this as well. But it is troubling to look at the number of folks needing medical assistance and the cost of devices. But I think if you look at the GPO issue, where you allow as many players as possible into the marketplace, then you are going to have truly the best product at the lowest price." Leahey believes there are steps that can be taken to address these issues. "We can work with the administration, work with Congress as far as adequate reimbursement levels, and also address some of the competition questions to ensure that everyone has an opportunity to contribute and that hospitals truly are getting the best product at the best price."

Leahey is a member of numerous healthcare organizations, the American Bar Association, and the Massachusetts Bar Association. He is a graduate of Georgetown University and the Georgetown Law Center. He succeeds Larry Holden, who plans to pursue other business opportunities. Paul Touhey, MDMA board chairman, says of Holden, "Larry was instrumental in asserting the position of the research-focused, entrepreneurial medical device sector in the public policy debate."

Copyright ©2003 Medical Device & Diagnostic Industry